Post-discharge risk-based care after major elective cancer surgery

A Randomized Controlled Trial of Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)

This trial tests whether more intensive post-discharge monitoring helps adults who have had major elective cancer surgery recover more safely than standard follow-up.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 880 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fox Chase Cancer Center (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT05454280 on ClinicalTrials.gov

What this trial studies

Adults with probable or confirmed primary or recurrent malignant tumors who are scheduled for major elective cancer operations at Fox Chase Cancer Center are stratified by procedure type and randomized to intensified post-discharge surveillance or standard surveillance. The intensified arm receives enhanced, risk-based monitoring after hospital discharge while the control arm receives the usual surgeon-directed follow-up. Outcomes are tracked through post-discharge day 30 for deaths, complications and adverse events, through the end of the index hospitalization for ICU stays, length of stay and return to the operating room, and through post-discharge day 90 for readmissions, quality of life, and receipt of anti-neoplastic therapy. This is a Phase 3, single-institution randomized comparison designed to determine whether targeted post-discharge care changes clinical and recovery outcomes.

Who should consider this trial

Good fit: Adults (≥18 years) with probable or histologically/cytologically confirmed primary or recurrent malignancies scheduled for elective major cancer operations who have ECOG performance status 0–2 are the intended participants.

Not a fit: Patients having minor outpatient procedures, superficial skin cancer resections, biopsies, emergent operations, or those with ECOG >2 are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, the approach could lower post-discharge complications and readmissions and speed detection and treatment of problems after major cancer surgery.

How similar studies have performed: Enhanced post-discharge monitoring programs in surgical populations have sometimes reduced readmissions and detected complications earlier, but applying a risk-based intensified protocol specifically for high-risk major cancer surgery is relatively novel and is being tested here in a Phase 3 setting.

Eligibility criteria

First Registration Inclusion Criteria:

* Age \> 18 years at diagnosis
* ECOG performance status 0, 1, or 2, defined as

Grade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours

   * Patients must have probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage).

Patients undergoing major operations to resect or treat known or suspected malignancies of the head and neck, chest, abdomen, genitourinary tract, or extremities are eligible. Patients undergoing biopsies, outpatient procedures, superficial resections of cutaneous malignancies, or purely palliative operations are not eligible.

These procedures are commonly performed in patients with malignant neoplasms, malignant neuroendocrine tumors, or carcinomas in situ, and are commonly "tracked" by hospitals and cancer centers participating in the ACS NSQIP Procedure Targeted option because they are often associated with higher rates of postoperative morbidity and mortality (compared to other, less complex cancer procedures).

* Patient must be scheduled for elective major cancer surgery (as listed in 4.1.4) at FCCC \< 30 days after First Registration.

Elective surgery is defined as:

* Patient is scheduled to be brought from their home (or normal living environment) to FCCC on the day of the index surgery (or day prior as scheduled admission) AND
* Surgery is not scheduled as urgent or emergent

  * Ability to understand and willingness to sign a written informed consent and HIPAA consent document
  * Geographical accessibility and willingness to return to FCCC for all preoperative and postoperative study assessments.

First Registration Exclusion Criteria:

* Any condition that might interfere with the subject's participation in the study, compliance with study requirements, or in the evaluation of the study results.

Second Registration Inclusion Criteria:

A patient will be eligible for continued inclusion in this study only if ALL of the following criteria apply at the time of Second Registration (one to two days prior to anticipated discharge). No exceptions or waivers will be granted for patients who do not meet the eligibility criteria.

* Post

  * Elective (curative or palliative) major cancer surgery (as listed in 4.1.4 above) at the time of the index surgery (patient may have undergone more than one of these procedures) OR
  * Elective surgical procedure(s) listed as an option (i.e., CPT code) in the Surgical Risk Calculator webpage (patient may have undergone more than one of these procedures)

For the purposes of this study, the procedure that was performed with the highest estimated risk of DSC (as predicted by the Surgical Risk Calculator) will be denoted at the time of Second Registration as the "index procedure" performed during the "index surgery".

* Elective surgery \< 30 days after First Registration.

Second Registration Exclusion Criteria:

* Status post elective surgical procedure(s) not listed as options in the Surgical Risk Calculator webpage. This includes patients whose scheduled procedure was suspended due to unexpected findings, such as carcinomatosis.

Where this trial is running

Philadelphia, Pennsylvania

• Fox Chase Cancer Center - Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Jason Castellanos, MD — Fox Chase Cancer Center
• Study coordinator: Jason Castellanos, MD

Conditions Surgery; Cancer